glipiZIDE
Failed Dissolution Specifications:
Most common reason: Dissolution failure (9 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Glipizide. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Failed Dissolution Specifications:
Failed Dissolution Specifications: results were above specification.
Failed Dissolution Specifications: dissolution failure at time zero of the repackaged lot. Drug release results were slightly above specification at time zero.
CGMP Deviations; rejected product was used to manufacture final bulk lot
Failed Moisture Limits: out of specification test results for water content obtained during stability testing.
Failed Dissolution Specifications
Failed dissolution specifications: Glipizide 2.5 mg ER Tablets exceeded dissolution specification rates for the 10 hour testing point.
Failed Dissolution Specifications. Above out of specification for dissolution rate observed at the 10 hour testing point.
Presence of Foreign Tablets/Capsules; bottles of Glipizide 5 mg tablets may contain Glipizide 10 mg tablets
Failed Dissolution Specifications: Glipizide 2.5 mg ER Tablets exceeded dissolution specification rates for the 10 hour testing point.
Failed Impurities/Degradation Specifications: Out of specification for unknown impurity.
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Failed Dissolution Specification; the bulk lot yielded an out of specification result at the 8 hr timepoint, 18 month interval
Failed Dissolution Specification; 8 hr stability timepoint
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